Comparison of a rule-based algorithm with a phenotype-based algorithm for the interpretation of HIV genotypes in guiding salvage regimens in HIV-infected patients by a randomized clinical trial: the mutations and salvage study

There is still considerable uncertainty as to the best algorithm for interpreting human immunodeficiency virus (HIV) genotyping results. A total of 318 subjects with HIV RNA levels of >1000 copies/mL were enrolled in 41 centers throughout Italy from 2001 through 2003, stratified on the basis of t...

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Vydáno v:Clinical infectious diseases Ročník 42; číslo 10; s. 1470
Hlavní autoři: Gianotti, Nicola, Mondino, Vincenzo, Rossi, Maria Cristina, Chiesa, Elisabetta, Mezzaroma, Ivano, Ladisa, Nicoletta, Guaraldi, Giovanni, Torti, Carlo, Tarquini, Pierluigi, Castelli, Paula, Di Carlo, Aldo, Boeri, Enzo, Keulen, Wilco, Kenna, Paula Mc, Lazzarin, Adriano
Médium: Journal Article
Jazyk:angličtina
Vydáno: United States 15.05.2006
Témata:
Adult
Algorithms
Anti-HIV Agents - therapeutic use
Antiretroviral Therapy, Highly Active
Female
Genotype
HIV - genetics
HIV Infections - drug therapy
HIV Protease Inhibitors - therapeutic use
Humans
Italy
Male
Middle Aged
Mutation
Phenotype
Reverse Transcriptase Inhibitors - therapeutic use
RNA, Viral - blood
RNA, Viral - genetics
Salvage Therapy
Viral Load
Italy
ISSN:1537-6591, 1537-6591
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Shrnutí:There is still considerable uncertainty as to the best algorithm for interpreting human immunodeficiency virus (HIV) genotyping results. A total of 318 subjects with HIV RNA levels of >1000 copies/mL were enrolled in 41 centers throughout Italy from 2001 through 2003, stratified on the basis of their drug history, randomized (1:1) to 2 arms to have their treatments modified on the basis of the results of HIV genotyping (as interpreted by virtual phenotype analysis or with use of a rule-based interpretation system), and followed up for 48 weeks. At least 1 nucleoside reverse-transcriptase inhibitor and 1 protease inhibitor had to be included in any new regimen; nonnucleoside reverse-transcriptase inhibitor-naive patients were also prescribed a nonnucleoside reverse-transcriptase inhibitor. Only drugs licensed in Italy were allowed. The primary end point was a decrease in HIV RNA level to <400 copies/mL by week 12 according to on-treatment analysis. The mean (+/- standard deviation) values at baseline were as follows: HIV RNA level, 4.1+/-0.74 log(10) copies/mL; CD4(+) T lymphocyte count, 410+/-262 cells/microL; reverse-transcriptase mutations, 4.8+/-2.9; and protease mutations, 2.8+/-2.5. There were 133 patients (41.8%) who were nonnucleoside reverse-transcriptase inhibitor naive and protease inhibitor experienced, 63 patients (19.8%) who were nonnucleoside reverse-transcriptase inhibitor experienced and protease inhibitor naive, and 122 patients (38.4%) who were 3-class experienced. A total of 192 patients completed 12 weeks of the treatment regimen assigned at baseline; at 12 weeks, 66.3% of patients in the virtual phenotype arm and 71.3% of patients in the rule-based interpretation arm had HIV RNA levels of <400 copies/mL (P = .46). No statistically significant difference between arms was observed by intention-to-treat analysis. Both the virtual phenotype and rule-based interpretation methods of HIV genotyping can guide the selection of effective antiretroviral drugs for a salvage regimen.
Bibliografie:ObjectType-Article-1
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ISSN:1537-6591
1537-6591
DOI:10.1086/503568